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REZULIN: NIH Launches Formal Ethics Investigation

Dr. Harold Varmus, director of the National Institutes of Health, yesterday called for an internal review of allegations of a conflict-of-interest between the government's top diabetes researcher and a pharmaceutical company. The Los Angeles Times reports that the scandal is inviting closer scrutiny of the entire agency - - Varmus said the investigation will look at "the nature and extent of other arrangements" between NIH researchers and private companies and will decide whether NIH conflict-of-interest guidelines need "clarification." The move comes in response to last week's Los Angeles Times investigative report that exposed financial ties between Dr. Richard Eastman, who was conducting the government's largest ever diabetes study, and drugmaker Warner-Lambert Co., manufacturer of the diabetes drug Rezulin that was under examination. Varmus directed NIH's inspector general's office to investigate "whether any violation of law and/or regulations occurred," saying, "I am concerned about the questions that have been raised regarding NIH staff responsible for the oversight of the diabetes prevention study." Varmus added that it was "critical ... that NIH officials who oversee these studies adhere to the highest scientific and ethical standards."

Lonely At The Top? The IG office will also investigate Eastman's superiors to see if they approved the arrangement in violation of conflict-of-interest guidelines. Both Eastman and his boss, Deputy Institute Director Earl Laurence, have said that Eastman received the agency's permission to enter a consulting arrangement with Warner-Lambert. When asked whether subsequent developments might have interfered with Eastman's agency responsibilities, Laurence insisted, "No, I have not seen any interference." The Times reports that Laurence last month promised to "quickly provide copies of any authorization granted Eastman -- plus financial-disclosure documents showing the amounts of money" Eastman received. But NIH officials have stalled release of the records, saying they "must be reviewed to protect Eastman's privacy." Under federal law, it is illegal for a government official to participate "personally and substantially" in government decisions affecting a private employer, and NIH ethical guidelines are even clearer: NIH researchers are not to engage in consulting arrangements that could "interfere in any way" with agency responsibilities (Willman, 12/16).

Not So Fast In a letter to the Times, University of California-Los Angeles Clinical Diabetes Program Director Dr. Anne Peters blasts the paper's coverage of the Rezulin scandal as "one-sided." She concedes that Rezulin can cause liver failure, but asks, "[W]hat of the other classes of anti-diabetes drugs?" She writes, "All can cause death or serious illness at approximately the same rate as does Rezulin. ... Treatment risks must be weighed against the benefits of treatment and the risk of untreated disease." Peters defends Eastman as "a man with much integrity," and states that he does "what all of us do who care about patients with diabetes, using whatever resources he can to provide better opportunities for treatment and education." She concludes, "Are we 'owned' by the drug companies? Most are not" (12/16).

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